TISSUE AND BIOLOGICAL FLUIDS BANKS OF HIV-RELATED MALIGNANCIES
Release Date: April 24, 2001
RFA: RFA-CA-02-001 (Reissued as RFA-CA-08-501)
National Cancer Institute
Letter of Intent Receipt Date: July 13, 2001
Application Receipt Date: August 10, 2001
This RFA is a reissue of RFA-CA-94-003, which was published in NIH Guide
Volume 23, Number 2, January 14, 1994.
PURPOSE
The Office of the Director of the Division of Cancer Treatment and Diagnosis
(OD-DCTD), National Cancer Institute (NCI) invites applications from consortia
of institutions for cooperative agreements to bank tissue and biological
fluids and to maintain associated clinical data from patients with
HIV-associated malignancies. The purpose of the proposed awards is to
continue cooperative efforts to identify and improve access to tumor tissue,
biological specimens, and associated clinical outcome data that could then be
utilized for research, by the research community at-large, on the pathogenesis
of HIV-associated malignancies and development of more effective therapies.
RESEARCH OBJECTIVES
Background
Congenital and acquired states of immunodeficiency increase the incidence of
high-grade B cell non-Hodgkin’s lymphoma (NHL), Kaposi’s sarcoma (KS), and
certain types of epithelial malignancies. Individuals infected with human
immunodeficiency virus (HIV) have a marked increase in the appearance of
intermediate and high-grade B cell NHL and KS, and show trends for an
increased incidence for Hodgkin’s disease and anogenital dysplasia and cancer,
compared to age-matched controls. The tumors in HIV-infected individuals are
generally aggressive and insufficiently sensitive to conventional therapy.
Trends in the epidemiology and treatment of HIV have changed. As a result of
behavioral changes and highly active anti-retroviral therapy (HAART), the
incidence of KS and primary central nervous system lymphoma has decreased.
However, the incidence of NHL and intraepithelial neoplasias are not as
affected by immune reconstitution. Certain subtypes of NHL, such as T-cell
NHL and primary effusion lymphomas, are being detected more frequently. What
is not yet known, and needs to be prepared for, is the effect of prolonged
moderate immunodeficiency, incomplete or failed response to HAART, and perhaps
HAART itself on the establishment and maintenance of cancer. As HIV vaccine
trials begin, new questions will arise. Given the association of viruses with
many AIDS-related cancers, intense investigations are needed to identify the
pathogenic role of these viruses, especially Epstein-Barr virus, human
herpesvirus 8/Kaposi’s Sarcoma-associated herpesvirus, and human
papillomaviruses.
In recent years, the extramural research community has recognized the value of
biological fluids and tissue banks in supporting translational research. They
recognized that the most efficient method to obtain tumor specimens and bodily
fluids would take advantage of the meticulous follow-up and monitoring of
patients in the context of clinical trials in the institutions involved in the
care of patients with HIV-associated malignancies. Tumor tissue collected
during clinical trials would permit research on the pathogenesis of
HIV-associated malignancies and on the development of effective therapies.
Objectives and Scope
The purpose of the proposed awards is to continue the cooperative efforts of
the Tissue and Biological Fluids Bank of HIV-associated malignancies and to
maintain associated clinical and outcome data. The Banks would provide
critical resources to the research community at-large for research studies to
gain insight into the pathogenesis of the malignancies that arise in
HIV-infected individuals.
The current Tissue and Biological Fluids Bank of HIV-associated malignancies
is composed of five consortiums each made up of a minimum of two institutions
with an Operations Office that provides the necessary coordination of specimen
collection, and data management. Collection and storage of specimens are
performed at each institutional site that is part of each consortium.
Formation of a consortium of institutions is encouraged to maximize specimen
accession. All applicants must provide evidence of availability and access to
patient specimens, and each Consortium (made up of a minimum of two
institutions) must have an Operations Office that is capable of providing the
necessary coordination of specimen collection, data management, and storage of
specimens at a central location. Banked specimens may consist of fixed or
frozen tumor tissue and biological fluids. All specimens are collected and
banked according to common procedures developed up by the Tissue and
Biological Fluids Banks of HIV-associated malignancies.
The awardees will provide to the research community at-large tissue and
biological fluids of high quality from patients with HIV-associated
malignancies for high priority research studies. This task will be
accomplished through the workings of two committees, the Steering Committee
and the Research Evaluation and Decision Panel (REDP). The duties of these
two committees are described below under SPECIAL REQUIREMENTS.
SPECIAL REQUIREMENTS
Definitions
CONSORTIUM - a consortium must include a minimum of two institutions, which
join together under the guidance and direction of a single Principal
Investigator. Each consortium must have clinical laboratory and pathology
components representing diverse scientific disciplines.
AWARDEE - the organization to which a cooperative agreement is awarded and
which is responsible and accountable to NCI for the use of funds provided and
for performance of the cooperative agreement-supported project.
PRINCIPAL INVESTIGATOR (PI) - the single individual at the awardee institution
designated by the awardee in the cooperative agreement application, who is
responsible for the scientific and technical direction of the project.
OPERATIONS OFFICE - the central office at the Applicant/Awardee Institution
that handles all the clinical data and the tissue and biological fluids
repository data. The Principal Investigator serves as The Head of the
Operations Office and is responsible for supplying specimen update information
to the Central Operations and Data Coordinating Center at least 4 times/year.
CENTRAL OPERATIONS AND DATA COORDINATING CENTER – The administrative unit that
coordinates all the Consortium activities. Responsibilities include
administrative management and coordination of the workings of all awardee
Operations Offices, developing and maintaining a central database of available
tissue and clinical data, maintaining a database of repository samples from
the AIDS Malignancy Consortium and other NIH-funded cooperative groups,
responding to approved Letters of Intent, coordinating shipment and ensuring
receipt of samples, tracking progress reports of sample recipients, developing
a national outreach program, and ensuring adherence to the Office of Human
Research Protection regulations. The Central Operations and Data Coordinating
Center will be located at the same site as a Bank Consortium.
NCI PROGRAM DIRECTOR - The OD-DCTD extramural grants Program Director, who
interacts scientifically with the Applicant/Awardee Institutions regarding
basic science issues. The Program Director will also be coordinating DCTD"s
interactions and administering and providing guidance for the overall program
within the NCI. He/she is available for consultation during preparation of
applications as well as the duration of research conducted through this
cooperative agreement. He/she is the Executive Secretary of the Review and
Evaluation Decision Panel.
NCI COORDINATOR - The Deputy Director, DCTD, who interacts scientifically with
the Applicant/Awardee Institutions regarding clinical science issues.
STEERING COMMITTEE - a single Committee whose membership includes the NCI
Coordinator, the NCI Program Director, the PI and one other investigator from
each awarded cooperative agreement, and one research scientist with expertise
in the field of HIV-associated malignancies who is not affiliated with any of
the Awardee Institutions/Consortia. This research scientist on the Steering
Committee will be appointed by mutual agreement of the NCI Coordinator, the
NCI Program Director and the PIs. The Steering Committee will serve as the
governing board of the Tissue and Biological Fluids Banks of HIV-Related
Malignancies (see under "Terms and Conditions of Award" for function of
Steering Committee).
REVIEW AND EVALUATION DECISION PANEL (REDP) - A panel composed of the NCI
Program Director and six to eight scientists with clinical/basic research
expertise in the field of HIV-associated malignancies. The members of the
panel will evaluate all research (those of the awardees as well as proposals
from the research community at-large) proposing to utilize the specimen and
data Banks according to the evaluation and review criteria provided by the
Steering Committee. The panel will provide a recommendation to the Steering
Committee regarding the priority of the proposed research. The membership of
the REDP may vary, depending on the scientific areas of the proposed research
to be reviewed and evaluated. Except for the NCI Program Director, all
members will be selected by the Steering Committee (see under "Terms and
Conditions of Award" for function of REDP).
Study Organization and Function
The current overall structure of the Tissue and Biological Fluids Banks of
HIV-Related Malignancies consists of five funded Consortia that are governed
and coordinated through the Steering Committee. Each Bank or funded
Consortium is composed as follows: two or more member institutions of the
Consortium who are responsible for contributing specimens, biological fluids
and clinical data, an Operations Office at the awardee institution, and one PI
who is responsible for providing the scientific and administrative leadership
for the Consortium and serves as the Head of the Operations Office. A
separately funded Central Operations and Data Coordination Center will provide
administrative oversight to the consortia as described under Definitions.
The overall function of the Tissue and Biological Fluids Banks of HIV-Related
Malignancies is to continue to serve as a national resource to the research
community at-large. The Tissue and Biological Fluids Banks of HIV-Related
Malignancies will provide tissue specimens and clinical outcome data after the
requests for such specimens and data have been reviewed and prioritized by the
REDP and approved by the Steering Committee. Requests for specimens and data
from the awardees and their collaborators will be reviewed, prioritized by the
REDP and approved by the Steering Committee along with all other requests from
investigators in the research community at-large.
The following terms and conditions will be incorporated into the award
statement and provided to the Principal Investigator(s) as well as the
institutional official at the time of award.
Terms and Conditions of Award
These special Terms of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.
The administrative and funding instrument used for this program is a
cooperative agreement (U01), an assistance mechanism in which substantial NCI
scientific and/or programmatic involvement with the awardee is anticipated
during performance of the activity. Under the cooperative agreement, the NCI
purpose is to support and/or stimulate the recipient"s activity by involvement
in and otherwise working jointly with the award recipient in a partner role,
but it is not to assume direction, prime responsibility, or a dominant role in
the activity. Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the project as
a whole, although specific tasks and activities in carrying out the studies
will be shared among the awardees, the NCI Program Director and the NCI
Coordinator.
1. Awardee Rights and Responsibilities
The Awardee will have primary and lead responsibilities for the project as a
whole, including the following:
The Awardee will establish a bank, collect specimens and clinical data.
The Awardee Principal Investigator, and one other investigator from the
Consortium, will serve on the Steering Committee.
The Awardee Principal Investigator will ensure that a database of specimen
information is kept current, using software compatible with the Central
Operations and Data Coordinating Center database software. The Awardee
Principal Investigator will provide updated database information on a
quarterly basis as defined by the Steering Committee.
The Awardee will work together with the other Awardees and the Central
Operations and Data Coordinating Center through the Steering Committee to
establish uniform collection methods and policies, and to assure quality
control of specimens and data. The Awardee will be required to accept and
implement the common policies and procedures approved by the Steering
Committee.
The Awardee agrees to provide access to specimens and data to investigators
both within and outside of the awardees" institutions based on the
prioritization of research proposals set by the REDP and final approval by the
Steering Committee. The Awardee will abide by the decisions of the Steering
Committee based on recommendations from the REDP.
The Awardee will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.
The Awardee will ensure that all cooperating institutions must have an
approved assurance of compliance for the protection of human subjects on file
with the Office of Human Research Protection and that necessary IRB reviews
are conducted by the IRBs of the appropriate institutions in accordance with
45 CFR part 46 prior to the involvement of human subjects.
The Awardee must provide an annual progress report in its continuing
application to OD-DCTD, NCI, and a copy to the chairperson of the Steering
Committee, in a format that is standardized and compatible with the annual
progress reports from the other Awardees. Information on the operations of
the bank, specimen accrual and dispersement, are to be included.
The Awardee must cooperate with the following groups by serving as a resource
for either repository or donation functions: the AIDS-Malignancies Consortium,
a national clinical trials cooperative group funded by the NCI under separate
granting mechanism, the NCI-sponsored Clinical Trials Cooperative Groups, and
with the NCI-sponsored Epidemiology Cohort studies, the latter two also funded
by the NCI under separate granting mechanisms.
2. National Cancer Institute Staff Responsibilities
The NCI Coordinator and the NCI Program Director will have substantial
scientific-programmatic involvement during conduct of this activity through
participation in the Steering Committee and the REDP, respectively. They will
provide technical assistance, advice and coordination, assure that the
Steering Committee and the REDP follow the NIH guidelines on conflict of
interest issues and play critical roles in promoting the availability and use
of the Banks. The roles of the NCI Coordinator and the NCI Program Director
are to assist and facilitate, but not to direct activities of the Tissue and
Fluids Banks of HIV-related Malignancies.
The NCI Coordinator and Program Director will serve as a voting member on the
Steering Committee, may attend meetings of the REDP as an observer and will
serve as an information resource on the relevant NCI extramural awardees
likely to require the resources of the proposed banks. The NCI Program
Director will serve as the non-voting executive secretary of the REDP. He/she
will advise the ad hoc REDP members on the Steering Committee"s algorithm for
reviewing the proposals requesting biological specimens and clinical data and
will provide information on other relevant on-going NCI activities and help
answer any programmatic issues. Both NCI staff will serve on subcommittees of
the Steering Committee and the REDP as required.
The National Cancer Institute reserves the right to reduce the budget, to
withhold support, and to suspend, terminate or curtail a study or an award in
the event of substantial shortfall in specimen accrual, data reporting,
inadequate quality control in specimens or clinical data collection,
non-adherence to biohazard precautions, refusal to carry out the
recommendations of the REDP and Steering Committee, or substantial failure to
comply with the terms of award.
3. Collaborative Responsibilities
a. Steering Committee
The Steering Committee will serve as the governing board of the Tissue and
Biological Fluids Banks of HIV-Related Malignancies. The Steering Committee
is composed of the NCI Coordinator and Program Director, the PI and one other
investigator from each awarded Consortium, and one research scientist with
expertise in the field of HIV-associated malignancies who is not affiliated
with any of the Awardee Institutions/Consortia. This research scientist on
the Steering Committee will be appointed by mutual agreement of the Steering
Committee.
The Steering Committee has primary responsibility for developing and
evaluating policies for quality control of the specimens, and uniformity of
procedures across institutions, for promoting the availability and the uses of
the specimen bank, and for developing an algorithm for review and
prioritization of research proposals, to be used by the REDP, utilizing the
banked specimens and clinical data (e.g., based on scientific merit with high
priority awarded to investigators with funded grants). The NCI Coordinator
and Program Director will assist the other members of the Steering Committee
in all these tasks. Furthermore, the NCI Coordinator and Program Director
will serve as the scientific liaisons between the awardees and other program
staff of NCI who have previous experience in the establishment of tumor banks.
Each member of the Steering Committee will have one vote. One Chairperson
will be selected by the Steering Committee, and be someone other than the NCI
Coordinator or Program Director. The Chairperson, together with the Central
Operations and Data Coordinating Center, is responsible for coordinating the
Steering Committee"s activities, for preparing meeting agendas, for scheduling
and chairing meetings, and preparing an annual progress report, which will
include individual reports from each Awardee. Each Awardee is responsible for
timely preparation of this report, which will be submitted to the Central
Operations and Data Coordinating Center. The Central Operations and Data
Coordinating Center (CODCC) is responsible for providing documentation as to
the availability and accessibility of specimens and data for scientific
investigations (e.g., the PI of the CODCC will send the principal investigator
of an REDP reviewed high priority proposal a letter as to the availability of
the specimens, with a final letter to be sent stating that specimens and/or
data will be made available as requested when funding for the REDP reviewed
high priority proposal is documented. If the proposal is already funded at
the time it is submitted to the REDP and reviewed as high priority, then the
PI will send the final letter at that time). The only occurrence in which the
Steering Committee can overturn the recommendations of the REDP is when
specimens and/or data are not available.
Subcommittees will be established by the Steering Committee, as it deems
appropriate. The NCI Coordinator and Program Director will serve on
subcommittees as appropriate.
The Steering Committee will meet at a minimum of twice per year in conjunction
with the NCI Coordinator and the Program Director, to map strategies to
fulfill the objectives of their function, to develop operating procedures and
to evaluate progress. The initial meeting will occur immediately after
funding. The Steering Committee will also meet with the REDP once per year.
The NCI Program Director will attend the joint meeting of the Steering
Committee and REDP as a non-voting member.
The Steering Committee will select members of the REDP. The Steering
Committee in the conduct of all business matters will pay particular attention
to conflict of interest issues, especially in actions regarding recommended
prioritizations of the REDP.
b. Research Evaluation and Decision Panel
The REDP will serve the Steering Committee by reviewing and evaluating all
research submitted by the research community at-large as well as by the
awardees proposing to utilize the specimen and clinical data Banks A
recommendation in terms of priority of the proposed research will be provided
to the Steering Committee. The only occurrence in which the Steering
Committee can overturn the recommendations of the REDP is the unavailability
of the requested specimens and/or clinical data. The REDP will meet with the
Steering Committee at least once yearly, at one of the two scheduled Steering
Committee meetings.
The REDP will be composed of the NCI Program Director and six to eight
scientists with clinical/basic research expertise in the field of
HIV-associated malignancies. The members of the panel will evaluate all
research (those of the awardees as well as proposals from the research
community at-large) proposing to utilize the specimen and data Banks according
to the evaluation and review criteria provided by the Steering Committee. The
panel will provide a recommendation to the Steering Committee as to the
priority of the proposed research. The membership of the REDP may vary,
depending on the scientific areas of the proposed research to be reviewed and
evaluated. All members will be selected by the Steering Committee. The
Chairperson of the REDP will always be someone other than the NCI Program
Director.
The review of proposals can be conducted either in person, by conference call
or by mail at a minimum of twice per year. All reviews will be conducted
according to rules pertaining to conduct of reviewers for NIH grants,
contracts, and cooperative agreements, paying special attention to issues of
conflict of interest, whether real or apparent. The NCI Program Director will
serve as the executive secretary (non-voting role) for the review and will
forward the final recommendation to the Central Operations and Data
Coordinating Center for distribution to the Steering Committee. The NCI
Program Director in the role of executive secretary of review will inform and
advise the ad hoc REDP members on the Steering Committee"s algorithm for
review and prioritization of proposals, will provide information to the ad hoc
REDP members on the studies that have already been approved and on other
relevant on-going NCI activities so that redundant studies are not performed,
and will help answer any programmatic issues. The NCI Program Director also
plays an important role in the whole review process by lending a degree of
continuity with the Steering Committee, as the ad hoc REDP composition may
change depending on the expertise required to review the submitted research
proposals.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NCI may be brought to
arbitration. An arbitration panel will be composed of three members -- one
selected by the Steering Committee (with the NCI member not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by the NCI, and the third member selected by the two prior selected
members. This special arbitration procedure in no way affects the awardee"s
right to appeal an adverse action that is otherwise appealable in accordance
with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45
CFR part 16.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this program will
remain a cooperative agreement (U01), an assistance mechanism, in which
substantial NCI scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity. Under the cooperative
agreement, the NCI purpose is to support and/or stimulate the recipient"s
activity by involvement in and otherwise working jointly with the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity. Details of the
responsibilities, relationships, and governance of the study to be funded
under this cooperative agreement are discussed later in this RFA under the
section "Terms and Conditions of Award."
Awards and level of support depend on receipt of a sufficient number of
applications of high scientific merit. Because of the variation in numbers of
patients to be accrued, and specimens to be accessed, it is anticipated that
the size of awards will vary also. The total project period for applications
submitted in response to the RFA may not exceed five years. The anticipated
award date is June 1, 2002. Although this program is provided for in the
financial plans of the NCI, awards pursuant to this RFA are contingent upon
the availability of funds for this purpose.
This RFA is a one-time solicitation. At this time the NCI has not determined
whether or how this solicitation will be continued beyond the present RFA. If
it is determined that there is a sufficient continuing program need, the NCI
will either invite recipients of awards under this RFA to submit competitive
continuation cooperative agreement applications for review or re-issue the RFA
for re-competition. If the NCI does not continue the program, awardees may
submit grant applications through the usual investigator-initiated grants
program.
FUNDS AVAILABLE
Approximately $3.5 million in total costs per year for five years will be
committed to fund applications submitted in response to this RFA. It is
anticipated that 6 awards for the Tissue and Biological Fluids Banks of
HIV-Related Malignancies will be made, including one for the Central
Operations and Data Coordinating Center, and 5 for Bank Consortia. It is
anticipated that the award for the Central Operations and Data Coordinating
Center will be made for approximately $500,000 (including direct and
Facilities and Administrative costs) per year.
ELIGIBILITY REQUIREMENTS
This is a recompetition of a previously issued RFA. Domestic and Canadian
for-profit and non-profit organizations, public and private such as
universities, colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government are eligible to
apply. Foreign institutions other than Canadian are not eligible to apply or
be a collaborating institution. Canadian institutions are included because
many of them are members of the NCI-Sponsored Clinical Trials Cooperative
Groups and the NIAID-sponsored AIDS Clinical Treatment Units. Applications
must be from a consortium of no less than two institutions, which can include,
but are not limited to, the NCI-Sponsored Clinical Trials Cooperative Groups,
the NIAID-Sponsored AIDS Clinical Treatment Units, or a coalition of Cancer
Centers. New and experienced investigators are encouraged to apply.
Applications from minority individuals, women, and persons with disabilities,
are encouraged to apply as principal investigators.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding clinical scientific issues to:
Ellen G. Feigal, M.D.
Deputy Director
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Building 31, Room 3A44
Bethesda, MD 20892
Telephone: (301) 496-6711
Fax: (301) 496-0828
Email: ef30d@nih.gov
Direct inquiries regarding basic science or programmatic issues to:
Jodi B. Black, Ph.D.
Program Director
Office of the Director, Division of Cancer Treatment and Diagnosis
National Cancer Institute
Building 31, Room 3A44
Bethesda, MD 20892
Telephone: (301) 402-6293
Fax: (301) 496-0828
Email: blackj@mail.nih.gov
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8326
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8326
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov
Direct inquiries regarding fiscal matters to:
Kelli Oster
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8627
FAX: (301) 496-8601
Email: osterk@GAB.NCI.NIH.GOV
LETTER OF INTENT
Prospective applicants are asked to submit by July 13, 2001, a letter of
intent that includes a descriptive title of the proposed research, name,
address, and telephone number of the Principal Investigator, identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information allows the
NCI staff to estimate the potential review workload and to plan the review.
The Letter of Intent is to be sent to Dr. Jodi Black, listed above
under INQUIRIES.
SCHEDULE
Letter of Intent Receipt: July 13, 2001
Application Receipt Date: August 10, 2001
Review by NCAB Advisory Board: February 22, 2002
Earliest Anticipated Start Date: June 1, 2002
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. Applications kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, E-mail: grantsinfo@nih.gov. For those applicants with Internet
access, the 398 kit may be found at
http://grants.nih.gov/grants/funding/phs398/phs398.html.
Additional Materials to Include in the Application
It is critical that applicants clearly describe plans to accommodate stated
criteria and staff involvement as listed in the Terms and Conditions of Award,
and in the Review Criteria section.
Re-Competing Applicants
One Applicant should present the overview of the entire Consortium in its
current form. Individual applicants should state how their formed Consortium
composed of no less than two institutions will maintain and enhance their
specimen bank. This should be divided into two parts: 1) The investigators
should demonstrate their productivity during the previous 4 years of funding.
This should include documenting the types, quantities, and quality of
specimens and clinical/demographic data that have been obtained. Also, state
the numbers, types, and progress of proposals that have utilized their
resources. The investigators should list the projects proposed, and the
projects that are actually provided specimens, as well as the number of
specimens that are provided for the projects. The investigators should list
the publications (abstracts and papers) from such projects that have utilized
the specimens. The investigators should list their cost per specimen. The
investigators should detail how they have set up a common database for the
Banks. 2) The investigators should state how they will enhance their specimen
bank, e.g., in the operations center, the database, plans to incorporate new
research opportunities, as well as describe future contributions of specimens
in the upcoming years of funding. This should include documenting the types,
quantities, and quality of specimens and clinical/demographic data that will
be obtained, how they have utilized the feedback from the proposals that are
currently utilizing specimens and data on future specimens and data that
should be made available. The investigators should state and describe how
they intend to enhance their operations and database to incorporate new
research endeavors (e.g., AIDS Malignancy Consortium, NCI sponsored Clinical
Trials Cooperative Groups, NCI sponsored Epidemiology Cohorts, the NIH
sponsored VA Aging Cohort Study), and their anticipated cost per specimen.
The applicant for the Central Operations and Data Coordination Center should
budget for all administrative duties listed under Definitions and Terms of
Award, for computer needs and software upgrades, and for REDP and Bank
Advisors travel expenses.
New Applicants
The applicant should form a Consortium composed of no less than two
institutions to design and develop a specimen bank and document their access
to and numbers of HIV infected oncology patients in clinical trials. Details
on the mechanism for tissue accession and storage and procedures for clinical
data collection and storage need to be provided. The application should also
address quality control issues for the specimens and clinical data collected.
The application needs to address the types of specimens (frozen and fixed tumor
tissue, biological fluids) planned for inclusion in the bank. Tissues and fluids
to be collected should come from groups of patients that are treated uniformly
on standard therapeutic regimens or clinical trials where clinical and outcome
data are available. Examples of pathology and clinical data forms that will be
used should be provided in the appendix of the application. The application
should propose an approach to setting up a common database for the consortium.
Applicants should clearly describe the Operations Office, the facilities for
banking and data collection, the investigators" experience and expertise in
banking and the applicants" ability to obtain tumor tissue and biological
specimens from HIV-infected patients with malignancies. The application must
provide details on the appropriate facilities and biohazard precautions and
comply with all applicable Federal, State and Local regulations, laws and
ordinances in the operation of the Banks. Applicants must maintain a database
compatible with the existing Bank database and budget funding for necessary
computers and software.
The applicants must state a willingness to cooperate with other awardees in
developing policies for quality control and to share data with other awardees.
The applicants must state a willingness and should discuss their approach to
cooperate with the Steering Committee and the REDP in evaluating research
proposals utilizing specimens obtained in their bank(s) and to abide by the
decisions of the REDP in prioritizing such proposals, after final approval by
the Steering Committee based on specimen availability.
All Applicants
Each applicant must provide the name and qualifications for the second
investigator from the consortium on the Steering Committee. Each applicant
must also provide the name and qualifications of one scientist not affiliated
with its institution/consortium as a potential member of the Steering
Committee. In addition, each applicant must provide the names and
qualifications of two scientists not affiliated with its
institution/consortium as potential members of the REDP. Travel funds for two
investigators to attend two Steering Committee meetings per year should be
included in the budget.
All costs required for the proposed Banks must be included in the application
and must be fully justified. These costs include the collection and storage
of specimens, quality assurance, data management and analysis, and travel. An
estimate and explanation based on cost per specimen is required.
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Type the RFA number
on the label. Failure to use this label could result in delayed processing of
the application such that it may not reach the review committee in time for
review. In addition, the RFA title and number must be typed on line 2 of the
face page of the application form and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express service)
At the time of submission, two additional copies of the application must also
be sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8326
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8326
Applications must be received by August 10, 2001. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this announcement that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially the
same as one already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such an
application must include an introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the National Cancer Institute. Incomplete and/or non-
responsive applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the Division of Extramural Activities of the National Cancer Institute in
accordance with the review criteria stated below. As part of the initial
merit review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review by the
National Cancer Advisory Board.
Review Criteria
The criteria to be used in the evaluation of grant applications are listed below.
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
Extent to which the application address the goals and objectives of the RFA,
Adequacy of applicant"s plans for addressing the special scientific and
technical program requirements presented in the RFA,
Merit of the proposed activities and organizational plans for implementing the
proposed Tissue and Biological Fluids Banks of HIV-Related Malignancies,
Qualifications and experience of the Principal Investigator and staff,
particularly, but not exclusively, in the area of the banking facilities and
procedures and clinical data collection,
Adequacy of existing physical facilities and resources of the organization,
Demonstration of the numbers of patients with HIV-associated malignancies
accessible to the investigators for clinical data and specimen collection,
Adequacy of plans for effective cooperation and coordination among
participating awardees, the NCI Program Director and the NCI Coordinator, as
per Special Requirements of the RFA,
Past contributions of specimens to the Tissue and Biological Fluids Banks of
HIV-Related Malignancies if applicable,
The initial review group will also examine: the appropriateness of proposed
project budget and duration, the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects, the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion, the provisions for the protection of
human and animal subjects, and the safety of the research environment.
AWARD CRITERIA
Applications recommended by the National Cancer Advisory Board will be
considered for award based upon (a) scientific and technical merit of the
application based on priority score, (b) availability of resources, and study
populations, and (c) availability of funds. Furthermore, the applicant
organization must indicate a commitment to accept provisions outlined under
the SPECIAL REQUIREMENTS section, terms and Conditions of Award. The
anticipated date of award is June 1, 2002.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub- populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups, if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
“NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects” that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy published in the NIH Guide for Grants and Contracts, June 5, 2000
(Revised August 25, 2000), available at the following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA, Tissue and Biological Fluids
Bank of HIV-Related Malignancies, is related to priority area of AIDS and
cancer. Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.395, Cancer Treatment Research. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.